Seasonal allergic rhinitis MedDRA version: 9.1 Level: LLT Classification code 10039776 Term: Seasonal allergic rhinitis
Conditions
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject is healthy. 2. Male or female between 18 and 50 years inclusive. 3. A female subject is eligible to participate if she is of: • Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. • Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the end of the study. 4. Body mass index less than 29.0 kg/m² with weight range of 55.0kg (females 50kg) to 95.0kg inclusive. 5. The subject has a history of seasonal allergic rhinitis. 6. The subject exhibits a moderate response to 1500 grass pollen grains/m3 after 2 hours in the Vienna Challenge Chamber, defined as a nasal symptom score of at least 6. 7. The subject has a positive skin prick test (wheal = 4mm) for grass pollen at or within the 12 months preceding the screening visit. 8. The subject has a positive RAST (= class 2) for grass pollen at or within the 12 months preceding the screening visit. 9. The subject is a current non-smoker who has not used any tobacco products in the 6 months preceding the screening visit with a pack history of = 10 pack years. 10. The subject must have a baseline FEV1>80% predicted and a baseline FEV1(maximum recorded value)/FVC(maximum recorded value)>70% predicted. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing females 2. Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception. 3. On examination the subject is found to have any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or recent or ongoing upper respiratory tract infection 4. Any respiratory disease other than mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists and associated with normal lung function. 5. The subject is likely to be unable to abstain from salbutamol use for 8 hours before a challenge 6. The subject has a screening QTc(B) value >450msec, PQ interval outside the range 120 to 240msec or an ECG that is not suitable for QT measurements. In addition subjects will be excluded if they have a history of atrial and ventricular arrhythmia. 7. A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening. 8. A supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening. 9. The subject has donated a unit of blood (450mL) within the previous 3 months or intends to donate within 3 months of completing the study. 10. The subject has used oral, injectable or dermal steroids within 5 weeks or intranasal and/or inhaled steroids within 1 week of the screening visit. 11. The subject has an elevated Troponin T above the normal range. 20. The subject, as deemed by the Investigator has a clinically significant CK-MB value above the normal range.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate effect of repeat intranasal doses of azelastine hydrochloride alone vs. GSK256066 + azelastine hydrochloride on nasal symptoms of allergic rhinitis provoked by spending 4h in the Vienna Challenge Chamber.;Primary end point(s): Weighted mean total nasal symptom score (sneeze, itch, rhinorrhoea and obstruction) 1-4h post morning dose period spent in the Vienna Challenge Chamber on Day 8.;Secondary Objective: To explore effects of repeat doses of azelastine hydrochloride alone vs. GSK256066 + azelastine hydrochloride on eye and global symptoms, nasal obstruction and secretions in allergic rhinitis provoked by spending 4h in the Vienna Challenge Chamber. To explore the safety and tolerability of repeat doses of GSK256066 in combination with azelastine hydrochloride in mild to moderate allergic rhinitic subjects. | — |
Countries
Austria
Outcome results
None listed